Development Delay, Premature Birth, Prematurity
Conditions
Keywords
quantitative EEG, Spectral Density Analysis, At Risk for Cognitive Delay, Premature Birth 28-32 weeks gestation
Brief summary
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.
Detailed description
This will be a randomized placebo-controlled clinical trial. Infants consented to participate will be randomized into the intervention arm or non-intervention arm by sealed unmarked envelope. All consented participants will have an initial EEG of 60-90 minutes duration, performed at 32 5/7 - 32 6/7 weeks (and after 72 hours of life). Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), eligible subjects will proceed with randomized intervention or placebo for a 2-week (14 day) intervention period. All infants will receive a 2nd EEG of 30-60 minutes duration, performed between 35 0/7 - 35 6/7 weeks corrected gestational age, following completion of either the intervention or non-intervention arm (with the goal of the 2nd EEG occurring within 48 hours of infants having completed the intervention vs. non-intervention arm). EEG technician and all persons reviewing, pruning and analyzing data from the qEEG will be blinded to whether the infant was in the intervention or the non-intervention arm.
Interventions
BEHAVIORALRecorded Maternal Voice
60-minute looped recording of maternal voice, played once daily for 14 total days.
BEHAVIORALPlacebo Recording
60-minute blank recording played once daily for 14 total days.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
NICU Investigator will provide the intervention versus placebo, with subject identification unlinked to randomization status. EEG reader, qEEG pruner and qEEG analyst will remain blinded to subject allocation until all data is extracted from each subject's EEG and medical record. To further prevent bias, group assignment unidentified as to control versus intervention will be maintained until all statistical analysis is complete.
Intervention model description
Crossed design, between-group and within-group pre- and post-intervention changes in primary variable.
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 33 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants born at 28 0/7 - 32 3/7 weeks gestation (to allow for infants born at 32 3/7 weeks to have initial EEG performed after 72 hours of life and prior to initiating intervention or non-intervention arm at 33 0/7 weeks gestation) * Mother available to provide voice recording, and have ability to converse and read in English (as the scripted content for the intervention will be provided in English)
Exclusion criteria
* Infant with Critical Congenital Cardiac Disease * Infant with Chromosomal anomaly or Inborn Error of Metabolism * Infant with known Neurologic disorder/abnormality - including hypoxic-ischemic encephalopathy (HIE), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), seizure activity, anatomic abnormality * Infant receiving antiepileptic or sedation medications prior to EEG * Initial EEG abnormal with epileptiform activity or not consistent with corrected gestational age * Mother not available to provide voice recording in English * Unable to obtain consent from mother due to maternal health issues following delivery (such as mother requiring intubation or sedation following delivery * Mothers who are prisoners (as the study team would like to have continuing communication during the study period as needed) * Mothers who are \<18 years of age will not be approached for consent * Any mother that is not able to consent due to having a legal representative will not be approached for consent * Any infant that is planned to be placed for adoption, is in foster care or is a ward of the state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| qEEG change: within | 2 weeks | Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band |
| qEEG change: between | 2 weeks | Difference in relative spectral power, between groups, of alpha (8-13 Hz) and beta (14-20 Hz) band, at baseline and post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to hospital discharge (between groups) | Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks. | Birth Date to NICU discharge Date |
| Feeding | Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks. | Time to full nippled feeds prior to discharge (between groups), gathered retrospectively by chart review at NICU discharge date. |
| NEC/Sepsis | Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks. | Episodes of necrotizing enterocolitis (NEC) and/or Sepsis (between groups), gathered retrospectively by chart review at NICU discharge date. |
| Duration of O2 support | Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks. | Duration of supplemental O2 needs (between groups), gathered retrospectively by chart review at NICU discharge date. |
Countries
United States
Outcome results
None listed